ISSUE UPDATE – Patent Reform
With patent reform legislation yet to be considered in the U.S. Senate, stakeholders with concerns about certain provisions in the bill continue to advocate changes:

• On Feb. 25, more than 170 California companies and organizations, including CHI, signed onto letters to Senators Dianne Feinstein and Barbara Boxer, arguing that the Patent Reform Act of 2007 “would increase costs to obtain and maintain patents, undermine patent certainty, incentivize infringement, and weaken the enforceability of patent rights and intellectual property protections.”
• On Feb. 26, the Change to Win Labor Federation, including the Service Employees International Union (SEIU), the International Brotherhood of Teamsters, and the United Food and Commercial Workers International Union (UFCW), submitted a letter to all Senate offices addressing their concerns with the measure.  The Change to Win letter concluded that passage of the Patent Reform Act “without significant modification would jeopardize, rather than encourage, economic innovation and growth that would benefit the vast majority of working Americans.”
• On Feb. 27, the Motor and Equipment Manufacturers Association (MEMA) submitted a letter to all 100 Senate offices expressing concerns with the measure.  In the letter, MEMA argues that several provisions included in the bill would “have the opposite effect” of “keep[ing] the United States the leader in technological innovation.”

Senate leadership has indicated that the Patent Reform Act will likely be considered in April, when the body reconvenes from its Easter recess.  CHI will continue to call for constructive changes to the measure before it comes up for a final vote.  For more information, contact Todd Gillenwater, CHI vice president-public policy at (202) 974-6313 or gillenwater@chi.org.

Increase in Funds Critical for Agency to Fulfill its Mission
Following the release of the president’s budget, which requests a modest increase of $51 million for the U.S. Food and Drug Administration (FDA), lawmakers and outside stakeholders have reinvigorated their push to obtain additional resources for the agency.  In response to a request from House Energy and Commerce Democrats, the FDA’s science and technology subcommittee issued an assessment on Tuesday, Feb. 26, estimating the agency will need to expand its budget by $375 million in FY ‘09 to reverse long-standing funding insufficiencies that have hampered its ability to secure the safety of drugs, medical devices and food.  The additional money would be used for implementing recommendations made by the subcommittee in December.  These centered on improving the agency’s scientific base, manpower, and technology needed to fulfill its mission.  A similar request for review has been made to the Government Accountability Office (GAO) from House and Senate Democrats.  Additional funding for FDA is an important objective for CHI and our members to ensure that the agency has the resources to review the next generation of innovative new medical therapies and technologies.  CHI will communicate our priorities with members of the California delegation who sit on committees with jurisdiction over the FDA outlining our priorities.

House and Senate to Tackle Tough Budget Negotiations
The House and Senate Budget Committees are expected to enter into tough negotiations this week on a budget package as both political parties stake out their priorities for the upcoming year.  It is anticipated that the committees will move legislation toward the end of the week, setting up a lengthy floor debate prior to the Easter recess.  Discussions will include tax policy and the president’s tax cuts, set to expire in 2010, as well as a Medicare package that could include an expansion of the State Children’s Health Insurance Program, a two-year halt on a physicians’ pay cut and increases to several other Medicare and Medicaid benefits.  CHI will closely monitor the negotiations, as the budget may become a vehicle for various policy objectives including Medicare D non-interference, drug importation and comparative effectiveness research.

Supreme Court Ruling on Medical Devices Garners Attention from Legislature
On Wednesday, Feb. 20, the Supreme Court ruled eight to one that medical device companies are released from liability lawsuits if their products pass FDA’s pre-market approval process.  This decision has reignited a congressional debate about whether FDA approval of a product pre-empts state law.  Powerful legislators, including Senate Health, Education, Labor and Pensions (HELP) Chairman Ted Kennedy (D-MA), House Oversight and Government Reform Chairman Henry Waxman (D-Los Angeles) and House Energy and Commerce Health Subcommittee Chairman Frank Pallone (D-NJ) have all indicated that the ruling to give manufacturers immunity goes beyond the scope intended in the original statute. Legislative action is likely.

Governor Announces Date for Special House Election
Gov. Arnold Schwarzenegger has scheduled an April 8 special election to fill the seat left vacant by the death of Rep. Tom Lantos (D-San Mateo).  If no candidate receives more than 50 percent of the vote, a runoff between the top vote getters in each party will be held on June 3, the same date as the state’s congressional primaries.  In a heavily Democratic district in the heart of one of the state’s major biotech clusters,  the election favors current front-runner, State Senator Jackie Speier.  Other candidates include Democrats Robert Barrows and Jason Lee Jones and Republican Mike Moloney.  For more information contact David Burt, CHI legislative director at (858) 551-6677 or burt@chi.org.